Research Recommendations

NCAI Policy Research Center works with tribes and other partners to respond to consultations and requests for input from federal agencies and other entities as needed to ensure that tribal research priorities are included.

 

Comments and Recommendations:

 

NIH Tribal Consultation on COVID-19 Research

* Input due to NIH by Friday, June 5, 2020 *NIH will still accept letters this weekend (6/6-6/7/2020) - for updates go to NIH THRO website here. View our letter here.

The National Institutes of Health (NIH) held a tribal consultation session on Thursday, May 28, 2020 to discuss planned research on current or new COVID-19 diagnostic tests and their implementation, and antibody testing in the All of Us Research Program participants. They are planning to fund researchers to conducting the diagnostic testing research in underserved communities and are proposing to conduct this research in tribal communities. The All of Us Research Program previously agreed to not use any AI/AN data and not recruit until tribal consultation was completed.

The relevant documents for the tribal consultation are listed below:

- Dear Tribal Leader Letter

- Framing Paper

- Agenda

- NIH PowerPoint slides

- Video of virtual Tribal Consultation session

NCAI letter submitted to NIH in response to the tribal consultation  - view here.

 

 

-       UPDATE FROM NIH (05/08/2020)

The National Institutes of Health (NIH) sent a letter to NCAI with an update on several existing tribal consultations. Read the letter here

 

DATA SHARING

• NIH DRAFT Data Management and Sharing Policy. The National Institutes of Health (NIH) initiated a consultation on data sharing and management for NIH funded or supported research on April 17, 2019. View the NIH letter. NCAI hosted a webinar with NIH on the topic. On November 8, 2019, NIH issued a Request for Public Comments on a DRAFT NIH Policy for Data Management and Sharing and Supplemental DRAFT Guidance in the Federal Register. NCAI sent a letter to NIH in response to the tribal consultation with comments on the draft and a request for tribal consultation on the draft policy. View the NCAI letter here. The NIH plans to consult with tribal nations on this draft policy in 2020 before a final policy is published. 

 

DISCLOSURE AVOIDANCE SYSTEM/DIFFERENTIAL PRIVACY - U.S. CENSUS BUREAU

• U.S. Census Bureau Tribal Consultation on Differential Privacy. The U.S. Census Bureau initiated a tribal consultation on its 2020 proposed data products and its plans for disclosure avoidance (privacy protection) that include implementation of a statistical method called Differential Privacy.  NCAI sent a letter to the U.S. Census Bureau after much deliberation with a team of data experts and passed a resolution calling on the U.S. Census Bureau to ensure that the 2020 Census data is confidential, accurate, and accessible for tribal governance purposes. Read the U.S. Census Bureau tribal consultation letter, our NCAI response letter, NCAI resolution, and use our template for your letter as soon as possible.  You can also read our research update on Differental Privacy and view our recent webinar to learn more about this topic.

Read our letter to the U.S. Census Bureau on 4/23/2020 in response to their request for comments on proposed 2020 Census Disclosure Avoidance System (DAS) Improvement Metrics here. Meaningful tribal consultation is needed on implementation of any privacy methods on the 2020 Census before final decisions are made. 

Read our letter to the US Census Bureau on 6/25/2020 requesting immediate consultation and a solution to ensure accurate 2020 census data for priority use cases important to tribal nations here.

View our webinar A Guide to 2020 Census Data Privacy on August 27, 2020 here with an update on analyses of demonstration data and the impact of the U.S. Census Bureau's new privacy methods on data released in July 2020.

Read our letter to the US Census Bureau on 9/9/2020 requesting immediate tribal consultation before the Data Stewardship Executive Policy Committee meets and makes certain decisions on the DAS in September 2020 here.

Analysis is in progress on the most recent demonstration data release on 9/17/2020 to determine if recent changes in privacy methods result in more accurate data for tribal nations. Watch for updates here.


ALL OF US RESEARCH PROGRAM

• NIH Consultation on the All of Us Research Program - NCAI Letter. NCAI submitted a letter with formal comments to the NIH tribal consultation on the All of Us Research Program that was initiated on March 24, 2019. NCAI wrote a previous letter on September 30, 2019 requesting the tribal consultation deadline be extended , and NIH did extend the deadline to November 30, 2019.  NCAI encourages tribal nations to submit letters by the deadline, and a template letter is included below along with our letter, its attachments, the prior letter, and the NIH tribal consultation letter and materials. We have also included a link to the NCAI Policy Research Center webinar on this topic in June 2019. NIH indicates that it will publish a summary of the consultation input by summer 2020. For now, NIH has agreed to not actively recruit AI/ANs on tribal lands and not make public data from any AI/ANs already recruited to participate until the tribal consultation input is considered. The NIH Tribal Advisory Committee is monitoring the outcomes of the tribal consultation. Tribal nations should make sure they have tribal research laws and policies in place that govern research, data ownership, and intellectual property rights from research.

-- NCAI letter - All of Us Research Program Tribal Consultation - November 26, 2019

----Attachment 1 - NCAI Resolution#ABQ-19-061 - Calling Upon the National Institutes of Health to Consult with Tribal Nations and Establish Policies and Guidance for Tribal Oversight of Data on Tribal Citizens Enrolled in the All of Us Research Program

---- Attachment 2: NCAI Policy Research Center Research Update - Intellectual Property Rights and Tribal Nations (October 2019)

---- Attachment 3: NCAI Policy Research Center Rsearch Policy Update - Final Rule: Part 3 - Informed and Broad Consent (January 2019)

---- Attachment 4: NCAI Policy Research Center Policy Update - Final Rule: Part 5: Tribal Research Codes (January 2019)

---- Template letter

-- NCAI Letter requesting NIH to extend the time for comments to the consultation (see paragraph below, September 30, 2019)

-- NIH Tribal Leader Letter initiating the All of Us Research Program tribal consultation (May 24, 2019) and Framing Letter

-- NCAI Policy Research Center Webinar Series - All of Us Research Program Overview (June 2019) video and slides

-- NIH All of Us Research Program Tribal Collaboration Working Group Report (April 4, 2018)

-- NCAI Policy Research Center Research Policy Update - NIH All of Us Research Program - An Update for Tribal Leaders (February 2018)

• NIH Consultation on the All of Us Research Program. NCAI letter with comments about the NIH tribal consultation process, the need for an extension of time for comments, clearer timelines, challenges with RFI process, need for government to government consultation, protection of AI/AN data until consultation completed, and importance of incorporating tribal oversight into the process for the All of Us Research Program.

 

INTELLECTUAL PROPERTY RIGHTS IN BIOMEDICAL RESEARCH

• NIH Consultation on Intellectual Property Rights in Biomedical Research - NCAI Letter with comments to NIH tribal consultation letter dated April 17, 2019  on NIH policies on Intellectual Property, Inventions, and Patent Rights in Biomedical Research. NCAI encourages tribal nations to submit comments. For more information, view the NIH letter, framing paper, webinar, and slides from the NCAI Mid Year Conference NIH tribal consultation on our 14th Annual Tribal Leader/Scholar Forum proceedings page here.

 

DIFFERENTIAL PRIVACY - 2020 CENSUS

• US Census Bureau - NCAI Letter calling for immediate tribal consultation on the topic of differential privacy and access to AI/AN Census data. The U.S. Census Bureau plans to implement enhanced privacy protections for the 2020 Census which may limit access to certain AI/AN data tables. If you would like to send a simlar letter, here is a template letter (7/26/2019) and our research policy update on this topic.

 

PAST RESEARCH RECOMMENDATIONS

• NIH RFI - Proposed Provisions for a Draft NIH Data Management and Sharing Policy (12/10/2018). This NIH RFI was released in 2018 with limited questions for public response. The NIH DRAFT Data Management and Sharing Policy was then released in the federal register in 2019 - see above for the NCAI response letter.

 

•  NCAI Summary of Proposed Changes and Comment Submission Details for the Notice of Proposed Rulemaking (NPRM) to Revise the "Common Rule" (11/18/15)

• Tracking Federal Research Priorities (The Common Rule NPRM 2015)

• Measuring Community Change & Impact to Improve Youth Wellness (08/20/2015)

• NCAI Comments on Draft NIH Genomic Data Sharing Policy (11/20/2013)

NCAI Comments on Advanced Notice of Proposed Rulemaking for “Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators” (10/25/2011)

• National Indian Health Board Letter to the National Institutes of Health regarding NIH Research Funding and Review for American Indian/Alaska Native Populations (11/7/2013)

NIH Reports on Inclusion of Women and Minorities in Clinical Research

“Race, Ethnicity, and NIH Research Awards” (Ginther, et al. 2011) published in Science

Information on NIH’s efforts to eliminate Health Disparities, including opportunities for researchers with a dedicated commitment to Native communities

Tribally-Driven Research Agenda (2005)